FDA.reportPublic FDA data

Application 215822

Type
ANDA
Sponsor
VKT PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINEFAMOTIDINETABLET;ORAL10MGNoNo
002FAMOTIDINEFAMOTIDINETABLET;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215822-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2022-01-28
A215822-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2022-01-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-28bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-286a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215822-001FAMOTIDINE10MGTABLET / ORAL2022-01-281c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215822-002FAMOTIDINE20MGTABLET / ORAL2022-01-281c564ffb4f44…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Curist Acid ReliefFAMOTIDINE 20 MGLittle Pharma, Inc.0fdfcc7c-aeed-6bd0-e063-6394a90ae52d2026-07-16WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINETWIN MED LLC795afb99-a3f4-4ffc-a905-2f84f3d86e4c2026-06-16WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINETWIN MED LLC6d97c60e-e39d-4541-ab49-d0fe3b3fa8402026-06-16WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
Acid Reducer Maximum StrengthFAMOTIDINE 20MGGrocery Outlet0c85b203-3d09-4799-97a9-722ee207bbfb2026-03-20WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEGLENMARK THERAPEUTICS INC., USA95f51f27-d367-4cfd-a15f-7856c9e361fb2026-01-13WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
ndc (product): 72657-113
ndc (product): 72657-112
FamotidineFAMOTIDINESAFEWAYf18c1195-48a1-69dc-e053-2a95a90a40772025-12-18WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
Heartburn ReliefFAMOTIDINEShield Pharmaceuticals Corp4e02a443-1e4c-46a5-8323-03d749b8634a2025-12-09WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
Welmate Famotidine 20mgFAMOTIDINE 20MGYYBA Corp1ea3c6b6-4c1e-d93c-e063-6394a90a0dac2025-07-29WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
Welmate Famotidine 10mgFAMOTIDINE 10MGYYBA Corp1e19d0cc-65d7-8ec4-e063-6394a90a3d2a2025-07-29WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEFAMILY DOLLAR99698eea-6bf1-42e8-9f48-d58fc04373242025-06-06WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEBi-Mart140440fb-d420-490d-8d7d-4b01c8ed3a832025-06-01WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEBi-Mart9974aa5e-e03f-4459-934a-ece27a8307462025-04-01WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEGeri-Care Pharmaceutical Corp288a8f87-e84a-a77a-e063-6294a90a86db2024-12-05WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEGERI-CARE PHARMACEUTICAL CORP287601b0-04ba-9611-e063-6394a90a91802024-12-04WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
FamotidineFAMOTIDINEVKT Pharma Private Limited1c2cfb3c-eaa0-403f-9589-d706afc06f512024-05-22WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
ndc (product): 71821-010
ndc (product): 71821-012
FamotidineFAMOTIDINEVKT Pharma Private Limited4e5db906-992f-476b-9d97-63a4c582bbdc2024-01-25WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822
ndc (product): 71821-010
ndc (product): 71821-012
Acid ReducerFAMOTIDINEAllegiant Healthadc2721d-2ca7-4a47-bae1-be298fa1c1552024-01-16WarningsExact identifier
application applno (ANDA): 215822
application number: ANDA215822

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71821-010FamotidineFamotidineVKT Pharma Private LimitedANDACurrent
71821-012FamotidineFamotidineVKT Pharma Private LimitedANDACurrent
72657-112FamotidineFamotidineGLENMARK THERAPEUTICS INC., USAANDACurrent
72657-113FamotidineFamotidineGLENMARK THERAPEUTICS INC., USAANDACurrent